Science and Politics at the FDA

Pharmaceutical Executive: What do you think is the biggest misconception inside the pharma industry about the FDA?

Photo: Stu Rosner Photography

Daniel Carpenter: There are two. The first is that people tend to see the FDA as a monolith, when in fact it's an organization with sharp internal disagreements about process and outcomes. The second myth is that the FDA is power hungry. FDA officials usually want authority when they think they can use it for public health purposes, but there are also a lot of searching discussions within the agency about what constitutes a credible line of action, given a particular regulatory problem.

PE: The title of your book—"Reputation and Power"—highlights two themes at the heart of your approach to understanding the FDA. The reference to "reputation" may surprise many readers. As you explain in the book, reputation offers an alternative to the two most common (and opposing) ideological views—"regulatory capture" (the FDA as a servant to industry and its interests) and "regulatory overreach" (the FDA as an obstacle to industry and its innovations). Why this emphasis on reputation?

DC: A reputation is any set of beliefs that an audience holds about an individual or organization. What makes things complicated is that the audience is not homogeneous but a diverse population with varying interests and histories. So a reputation usually is a multifaceted set of beliefs. The same organization can have a good cop face, a bad cop face, or a facilitator face, and can show different faces to different audiences.

A reputation-based perspective succeeds where "capture" and "overreach" hypotheses fail. The "capture" explanation fails to account for most of the FDA's history, as many of the FDA's growing powers were strongly opposed by the pharmaceutical industry and the American Medical Association. An "overreach" hypothesis ignores the FDA's record of flexibility on a host of drugs, from HIV to cancer and even alternative medicine.

I'm not saying that a reputation-based account gets everything right, but it suggests that under some conditions the agency's approach to pharmaceutical innovation will be stringent and cautious; under other conditions, the FDA will be facilitative of drug development and will emphasize safety less (postmarket regulation is an example, until recently).

PE: What is the relationship between the political context of "power" and regulation as it plays out at the FDA?

DC: I understand power in three ways: directive, gate-keeping, and conceptual. Directive power is the ability of the FDA to order companies to do things such as inspections and manufacturing requirements. Gate-keeping power is the power that results from the FDA's ability to veto a new drug. When companies abandon what may appear to be an apparently promising and profitable compound in Phase II because they think that it will not meet the FDA's approval criteria, we rarely see that reported in the news. Yet the FDA's power has been exercised nonetheless, because companies and medical researchers are anticipating the FDA's behavior to inform their decisions.

Conceptual power is the ability of the FDA to shape the vocabulary, methods, and tools of medicine and drug development. The three-phase system of clinical trials and the architecture of bioequivalence are examples where the FDA officials established processes that have been replicated throughout the world, affecting the very nature of science.